Product:A mammogram is a low-dose X-ray picture of the breast. It is currently the most effective screening method of detecting breast cancer in its earliest, most treatable stages.

Purpose:The FDA is alerting patients who had mammograms at San Sebastian X-Ray in San Sebastian, Puerto Rico any time after February 27, 2011 about possible problems with the quality of mammograms performed. This does not mean that the results of the examinations were inaccurate, but it does mean that patients need to have their tests re-evaluated and should speak to their health care providers about whether their tests need to be repeated.

Summary of Problem or Scope:The FDA became aware of the problems associated with the accreditation of San Sebastian X-Ray, located at the following address:

Avenida Emerito Estrada #1486San Sebastian, Puerto Rico 00685

The FDA worked with the American College of Radiology (ACR) during San Sebastian’s accreditation renewal. During a subsequent review of a sample of mammograms performed at the facility between February 27, 2011 and February 27, 2013, results included poor quality mammograms.

Under the Mammography Quality Standards Act (MQSA) of 1992, the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States. This facility did not meet standards for mammography quality under that Act. The facility no longer performs mammography due to a denial of its accreditation by the ACR and the expiration of its MQSA certification by the FDA.

Recommendations/Actions:The FDA recommends the following for patients who had a mammogram at San Sebastian X-Ray any time after February 27, 2011:

If you have had a mammogram at another MQSA-certified facility since then, you should follow the recommendations from that facility.

If you have not had a mammogram at another MQSA-certified facility since then, follow these guidelines:

Talk with your current health care provider as soon as possible about the need for a follow-up exam.

If your health insurance will not pay for a repeat mammogram, you can call the National Cancer Institute’s (NCI) information at 1-800-422-6237 for a listing of MQSA-certified facilities near you that will provide free or low-cost mammograms.

FDA Activities:The FDA will continue to monitor this issue and keep the public informed as new information becomes available.

This safety communication is in keeping with the FDA’s commitment to inform the public about safety issues.

Contact Information: If you have questions about this communication, please contact the MQSA Hotline at 1-800-838-7715, email your question to MQSAhotline@hcmsllc.com or fax to 1-410-290-6351.